Notice2023-17262
Classification Categories for Certain Supplements Under the Biosimilar User Fee Amendments of 2022; Draft Guidance for Industry; Availability
Primary source
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Published
August 11, 2023
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Classification Categories for Certain Supplements Under BsUFA III." This draft guidance provides recommendations for applicants and FDA review staff on classification categories A, B, C, D, E, and F for original and resubmitted prior approval supplements submitted to approved applications under the Public Health Service Act (PHS Act). The commitment letter associated with the Biosimilar User Fee Amendments of 2022 (BsUFA III) sets forth these supplement classification categories and their associated review performance goals. This draft guidance is intended to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.
Full Text
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<title>Federal Register, Volume 88 Issue 154 (Friday, August 11, 2023)</title>
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[Federal Register Volume 88, Number 154 (Friday, August 11, 2023)]
[Notices]
[Pages 54626-54627]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2023-17262]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-D-1954]
Classification Categories for Certain Supplements Under the
Biosimilar User Fee Amendments of 2022; Draft Guidance for Industry;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Classification Categories for Certain Supplements Under BsUFA III.''
This draft guidance provides recommendations for applicants and FDA
review staff on classification categories A, B, C, D, E, and F for
original and resubmitted prior approval supplements submitted to
approved applications under the Public Health Service Act (PHS Act).
The commitment letter associated with the Biosimilar User Fee
Amendments of 2022 (BsUFA III) sets forth these supplement
classification categories and their associated review performance
goals. This draft guidance is intended to help applicants identify the
appropriate classification category and review goal date of the
supplement being submitted.
DATES: Submit either electronic or written comments on the draft
guidance by October 10, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2023-D-1954 for ``Classification Categories for Certain Supplements
Under BsUFA III.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002; or the
Office of Communication, Outreach, and Development, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002.
Send one self-addressed adhesive label to assist that office in
processing your requests. See the SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 1132, Silver Spring, MD 20993, 301-796-
1042, <a href="/cdn-cgi/l/email-protection#2556444b4157440b47404b514a4b654341440b4d4d560b424a53"><span class="__cf_email__" data-cfemail="7a091b141e081b54181f140e15143a1c1e1b54121209541d150c">[email protected]</span></a>; or Anne Taylor, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
entitled ``Classification Categories for Certain Supplements Under
BsUFA III.'' This draft guidance provides recommendations for
applicants and FDA review staff on classification categories A, B, C,
D, E, and F for original and resubmitted prior approval supplements
(hereafter ``supplements'') submitted to approved applications under
section 351(k) of the PHS Act (42 U.S.C. 262(k)).
These classification categories pertain to supplements for
biosimilar and interchangeable biosimilar products seeking the
following:
[[Page 54627]]
<bullet> To update prescribing information and, if applicable, FDA-
approved patient labeling (e.g., Patient Package Insert, Medication
Guide, Instructions for Use) with safety information that has been
updated in the reference product labeling and is applicable to one or
more indications for which the biosimilar or interchangeable biosimilar
product is licensed
<bullet> To receive licensure for an additional indication
<bullet> To remove an approved indication
<bullet> To receive an initial determination of interchangeability
This draft guidance is intended to help applicants identify the
appropriate classification category and review goal date of the
supplement being submitted. Section I.A. of the commitment letter
associated with the BsUFA III sets forth these supplement
classification categories and their associated review performance
goals. The full text of the proposed BsUFA III Commitment Letter can be
found on the Agency's web page ``BsUFA III: Fiscal Years 2023-2027,''
available at <a href="https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027">https://www.fda.gov/industry/biosimilar-user-fee-amendments/bsufa-iii-fiscal-years-2023-2027</a>.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Classification Categories for Certain Supplements Under BsUFA III.''
It does not establish any rights for any person and is not binding on
FDA or the public. You can use an alternative approach if it satisfies
the requirements of the applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information pertaining to the Biosimilar User Fee Program and for
the submission of biologics license applications under section 351(k)
of the PHS Act regarding biosimilar product applications,
interchangeable biosimilar product applications, and supplemental
applications have been approved under OMB control number 0910-0718. The
collections of information in 21 CFR 201.56 and 201.57 for the
submission of labeling have been approved under OMB control number
0910-0572. The collections of information pertaining to Medication
Guides for prescription human drug and biological products have been
approved under OMB control number 0910-0393. The collections of
information in 21 CFR part 601 for the submission of biologics license
applications, supplemental applications, and Form FDA 356h have been
approved under OMB control number 0910-0338.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs">https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs</a>, <a href="https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics">https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or
<a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 7, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-17262 Filed 8-10-23; 8:45 am]
BILLING CODE 4164-01-P
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